Phase 1/2 Study of AGN-241622 in Healthy Participants and Participants With Presbyopia

AbbVie

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Presbyopia

Treatments: Drug: AGN-241622; Drug: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT04403763

2011-101-013

Details and patient eligibility

About

The objective of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AGN-241622 ophthalmic solution for the first time in human participants

Enrollment: 80 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 40 to 65 at the time of study participation.
• Be a nonsmoker and nonuser of nicotine-containing products within the previous 1 year.
• Be able and willing to follow study instructions and complete all required study visits in the opinion of the study doctor.

Exclusion criteria

• History of alcohol or substance abuse within the 5 years prior to study participation.
• Enrollment in another investigational drug or device study within 30 days of study participation.
• Women who are pregnant, nursing, or planning a pregnancy during the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 7 patient groups, including a placebo group

Placebo Dose

Placebo Comparator group

Description:

Administered as single drop in one or both eyes

Treatment:

Drug: Vehicle

Cohort 1: AGN-241622 Dose 1 (Low Dose)

Experimental group

Description:

Administered as single drop in one eye

Treatment:

Drug: AGN-241622

Cohort 2: AGN-241622 Dose 2 (Medium Dose)

Experimental group

Description:

Administered as single drop in one eye

Treatment:

Drug: AGN-241622

Cohort 3: AGN-241622 Dose 3 (High Dose)

Experimental group

Description:

Administered as single drop in one eye

Treatment:

Drug: AGN-241622

Cohort 4: AGN-241622 Dose 1 (Low Dose)

Experimental group

Description:

Administered as a single drop in each eye

Treatment:

Drug: AGN-241622

Cohort 5: AGN-241622 Dose 2 (Medium Dose)

Experimental group

Description:

Administered as single drop in each eye

Treatment:

Drug: AGN-241622

Cohort 6: AGN-241622 Dose 3 (High Dose)

Experimental group

Description:

Administered as single drop in each eye

Treatment:

Drug: AGN-241622